Moderna, Merck announc e follow-up data on V940 with Keytruda

Moderna (MRNA) and Merck (MRK) announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157, V940, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma following complete resection. In this planned analysis occurring with a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 in combination with KEYTRUDA continued to demonstrate a clinically meaningful improvement in recurrence-free survival, reducing the risk of recurrence or death by 49% compared with KEYTRUDA alone. mRNA-4157 in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival, compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62%. Adverse events observed with mRNA-4157 in KEYNOTE-942 remain consistent with those previously reported. At a median planned follow-up of approximately three years, the number of patients reporting treatment-related Grade greater than or equal to 3 adverse events were similar between the arms for mRNA-4157 in combination with KEYTRUDA. The most common adverse events of any grade attributed to mRNA-4157 were fatigue, injection site pain, and chills. Based on data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines scheme, respectively, for mRNA-4157 in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma. Data from the primary analysis has been submitted for publication in a peer-reviewed journal.